Ability of Beta-glucan Supplementation to Augment Immune Function

Stress Clinical Trial

Official title:

A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Ability of Beta-glucan (to Augment Immune Function, Decrease URTI Incidence Rates, and Counter Immune Changes in Marathon Runners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769012
• Other study ID #: 19BIHK
• Status: Completed
• Phase: N/A
• Start date: December 27, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: December 2018
• Source: Kemin Foods LC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This proposed study is designed to assess the efficacy of a capsule containing beta-glucan taken orally daily as compared to a placebo capsule on the URTI symptoms, and the immune response change in marathon runners

Description:

At screening, an informed consent form will be given to the potential volunteer. They will be required to read the information and will be given the opportunity to seek more information if needed or provided with the option of taking the consent form home to review prior to making their decision. If agreeable, the volunteer will sign the consent form and receive a duplicate of the signed copy. Once consent has been obtained, the screening visit will proceed. Each volunteer will be sequentially assigned a screening number to be entered in the screening and enrollment log. Screening assessments include: review medical history, assess inclusion and exclusion criteria, vitals, study diary, URTI symptom questionnaire, bowel diary, and GI symptom questionnaire.

The next visit will be scheduled 14 days prior to their marathon date (baseline). Participants will be reminded to complete URTI questionnaire, daily study diary, modified GI symptoms and bowel diary in advance of this baseline visit. At baseline participants will begin daily completion of study diaries, URTI questionnaires, daily bowel diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires, and blood sample for the analysis of CRP and NK cell activity. In addition, on the day of the marathon the participant will be instructed to complete a muscle soreness assessment.

Two and four weeks post-marathon participants will return to the clinic for with unused investigational product, completed study diaries, daily URTI questionnaires, daily bowel diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires, and blood sample for the analysis of CRP and NK cell activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Males and Females 21-65 years age

2. Body Mass Index (BMI) > 18 kg/m2 to < 34.99 kg/m2

3. Willing to wash-out for nutritional supplements known to affect immune function

4. Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.

5. Agree to keep lifestyle habits consistent

6. Currently registered to participate in a full marathon and on a training regimen

7. Healthy as determined by laboratory results, medical history, and physical exam

8. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the occurrence of the trial

2. Verbal confirmation of previous major gastrointestinal surgery or other major digestive disorder which may interfere with the absorption of nutrients

3. Participant has a known allergy to the test material's active or inactive ingredients

4. Chronic consumption of beta-glucan supplements

5. Consumption of anti-inflammatory medications known to affect immune function

6. On antibiotics within 4 weeks of baseline

7. Currently taking antipsychotic medications

8. Prebiotics and probiotics unless on a stable regimen

9. Verbal confirmation of Type I or Type II diabetes or clinically important renal, hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder, or cancer to be assessed by QI

10. Verbal confirmation of a diagnosed chronic inflammatory condition

11. Verbal confirmation of autoimmune disease or if immune-compromised

12. Chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis, asthma, or wheezing

13. Current or history (within past 6 months) of tobacco use

14. Consumption of >14 standard alcoholic drinks per week

Related Conditions & MeSH terms

• Cold
• Cold Symptom
• Flu
• Flu Symptom
• Gastrointestinal Tolerance
• Stress
• Supplement

Intervention

Dietary Supplement:
• Beta-Glucan
95% beta-glucan sourced from whole cell Euglena Gracilis
• Placebo
microcrystalline cellulose

Locations

Country	Name	City	State
Canada	KGK Science Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Kemin Foods LC	KGK Science Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Cold/Flu Symptom Severity Score Wisconsin Upper Respiratory Symptom Survey (WURSS)	AUC for cold/flu symptoms from Wisconsin Upper Respiratory Symptom Score	ANOVA with 2 and 4 weeks post-marathon
Secondary	URTI Cold/Flu Symptoms from Wisconsin Upper Respiratory Symptom Survey	Total number of symptoms	ANOVA with 2 and 4 weeks post-marathon
Secondary	Severity of cold/flu symptoms from Wisconsin Upper Respiratory Symptom Survey	Total severity score (each symptom scored on scale of 0-no symptom to 7-severe symptom)	ANOVA with 2 and 4 weeks post-marathon
Secondary	URTI Episodes from Wisconsin Upper Respiratory Symptom Survey	Total number of URTI Episodes/person	ANOVA with 2 and 4 weeks post-marathon
Secondary	Sick days	Total number of sick days/person	ANOVA with 2 and 4 weeks post-marathon
Secondary	Sick days	Percentage of subjects with sick days	ANOVA with 2 and 4 weeks post-marathon
Secondary	Stress Level from the perceived stress scale	Change from baseline on the Perceived Stress Scale	ANOVA with 2 and 4 weeks post-marathon
Secondary	C-Reactive Protein	Change in concentration from baseline	ANOVA with 2 and 4 weeks post-marathon
Secondary	Natural Killer Cell Activity	Change from baseline	ANOVA with 2 and 4 weeks post-marathon
Secondary	Gastrointestinal symptoms	Total gastrointestinal symptom rating score (GSRS)	ANOVA with 2 and 4 weeks post-marathon